The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of prophylactic surgical closure of LAA in the prophylactic stroke prevention in patients undergoing aortic valve replacement (AVR) with a bioprosthesis who do not have AF prior to operation (clinicaltrials.gov ID NCT02321137).
This ongoing randomized controlled prospective open-label international multicenter trial will enrol 1040 patients undergoing aortic valve replacement with CHA 2 DS 2 -VASC score ≥2 but without an indication for anticoagulation at the time of enrolment. Patients will be randomized in 1:1 fashion to standard therapy + surgical closure of LAA vs. standard therapy alone. The primary end point is a composite of incidence of stroke/transient ischemic attack, systemic embolism and cardiovascular mortality at five years follow-up.
Kiviniemi T, Bustamante-Munguira J, Olsson C, Jeppsson A, Halfwerk FR, Hartikainen J, Suwalski P, Zindovic I, Copa GR, van Schaagen FRN, Hanke T, Cebotari S, Malmberg M, Fernandez-Gutierrez M, Bjurbom M, Schersten H, Speekenbrink R, Riekkinen T, Ek D, Vasankari T, Lip GYH, Airaksinen KEJ, van Putte B
A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery.
Am Heart J. 2021 Mar 30;237:127-134. doi: 10.1016/j.ahj.2021.03.014.